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510(k) Data Aggregation

    K Number
    K952802
    Device Name
    VISUWELL REAGIN II
    Manufacturer
    BIOMIRA DIAGNOSTICS, INC.
    Date Cleared
    1996-05-23

    (339 days)

    Product Code
    GMQ
    Regulation Number
    866.3820
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    Applicant Name (Manufacturer) :

    BIOMIRA DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Visuwell® Reagin II is an enzyme-linked immunosorbent assay for the in vitro qualitative detection of non-treponemal (reagin) antibodies as a screening test in syphilis serology. It is not intended for use in screening blood or plasma donors.
    Device Description
    Visuwell® Reagin II is an enzyme-linked immunosorbent assay for the in vitro qualitative detection of non-treponemal (reagin) antibodies in syphills serology. In this device, serum is incubated with a mixture of cardiolipin, lecithin, cholesterol dried to a polystyrene solid phase. Antilipid antibodies react with the lipoidal antigen to form an immune complex. The presence of non-treponemal complexed antibodies is detected with a monoclonal anti-human lgG-peroxidase conjugate. The presence of bound conjugate is detected by the addition of enzyme substrate and subsequent development of colour. The reaction is stopped by the addition of acid and colour intensity is determined spectrophotometrically at 450 nm. Test results are interpreted relative to a floating cutoff based on the negative control. Positive and negative controls are used for establishing test validity.
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